Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27705, USA.
N Engl J Med. 2009 Dec 10;361(24):2318-29. doi: 10.1056/NEJMoa0908628.
Cangrelor, a nonthienopyridine adenosine triphosphate analogue, is an intravenous blocker of the adenosine diphosphate receptor P2Y(12). This agent might have a role in the treatment of patients who require rapid, predictable, and profound but reversible platelet inhibition.
We performed a large-scale international trial comparing cangrelor with 600 mg of oral clopidogrel administered before percutaneous coronary intervention (PCI) in patients with acute coronary syndromes. The primary efficacy end point was a composite of death from any cause, myocardial infarction, or ischemia-driven revascularization at 48 hours.
We enrolled 8877 patients, and 8716 underwent PCI. At 48 hours, cangrelor was not superior to clopidogrel with respect to the primary composite end point, which occurred in 7.5% of patients in the cangrelor group and 7.1% of patients in the clopidogrel group (odds ratio, 1.05; 95% confidence interval [CI], 0.88 to 1.24; P=0.59). Likewise, cangrelor was not superior at 30 days. The rate of major bleeding (according to Acute Catheterization and Urgent Intervention Triage Strategy criteria) was higher with cangrelor, a difference that approached statistical significance (3.6% vs. 2.9%; odds ratio, 1.26; 95% CI, 0.99 to 1.60; P=0.06), but this was not the case with major bleeding (according to the Thrombolysis in Myocardial Infarction criteria) or severe or life-threatening bleeding (according to Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries criteria). A secondary exploratory end point of death from any cause, Q-wave myocardial infarction, or ischemia-driven revascularization showed a trend toward a reduction with cangrelor, but it was not significant (0.6% vs. 0.9%; odds ratio, 0.67; 95% CI, 0.39 to 1.14; P=0.14).
Cangrelor, when administered intravenously 30 minutes before PCI and continued for 2 hours after PCI, was not superior to an oral loading dose of 600 mg of clopidogrel, administered 30 minutes before PCI, in reducing the composite end point of death from any cause, myocardial infarction, or ischemia-driven revascularization at 48 hours. (ClinicalTrials.gov number, NCT00305162.)
坎格雷洛是一种非噻吩吡啶类三磷酸腺苷类似物，是一种静脉内的二磷酸腺苷受体 P2Y(12)阻滞剂。这种药物可能在需要快速、可预测和深度但可逆的血小板抑制的患者治疗中发挥作用。
我们进行了一项大规模的国际试验，比较了坎格雷洛与经皮冠状动脉介入治疗（PCI）前给予 600mg 口服氯吡格雷在急性冠脉综合征患者中的疗效。主要疗效终点是 48 小时时任何原因死亡、心肌梗死或缺血驱动的血运重建的复合终点。
我们纳入了 8877 例患者，其中 8716 例进行了 PCI。48 小时时，坎格雷洛在主要复合终点方面并不优于氯吡格雷，坎格雷洛组有 7.5%的患者发生该终点，氯吡格雷组有 7.1%的患者发生该终点（比值比，1.05；95%置信区间[CI]，0.88 至 1.24；P=0.59）。同样，30 天时坎格雷洛也不占优势。根据急性导管插入术和紧急介入治疗分类策略，使用坎格雷洛的主要出血（大出血）发生率更高，差异接近统计学意义（3.6%比 2.9%；比值比，1.26；95%CI，0.99 至 1.60；P=0.06），但根据心肌梗死溶栓治疗分类或全球应用链激酶和组织型纤溶酶原激活剂治疗闭塞冠状动脉分类，大出血或严重或危及生命的出血并不如此。次要探索性终点为任何原因死亡、Q 波心肌梗死或缺血驱动的血运重建，显示坎格雷洛有降低的趋势，但无统计学意义（0.6%比 0.9%；比值比，0.67；95%CI，0.39 至 1.14；P=0.14）。
在 PCI 前 30 分钟静脉内给予坎格雷洛并在 PCI 后 2 小时内继续给予，与 PCI 前 30 分钟给予 600mg 负荷剂量的氯吡格雷相比，在降低 48 小时时任何原因死亡、心肌梗死或缺血驱动的血运重建的复合终点方面并不占优势。（临床试验.gov 编号，NCT00305162）。
